| Primary Device ID | 00847627039644 |
| NIH Device Record Key | 82ba9790-a249-409c-b96e-4e5f6cc0fce7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CD163 |
| Version Model Number | NPAI353T40 |
| Company DUNS | 806617825 |
| Company Name | BIOCARE MEDICAL LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |